The FDA has approved an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.

The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use...

Monoclate (Armour), a formulation of Factor VIII (antihemophilic factor; AHF) prepared by immunoaffinity chromatography, was recently approved for marketing by the US Food and Drug Administration. The new product is claimed to be more highly purified than older AHF formulations. Factor VIII concentrates commercially available in the USA are listed in the table below.

HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.

High doses of estrogens, with or without a progestin, have been used for many years to prevent pregnancy after unprotected coitus (Medical Letter, 31:93, 1989). Now the FDA has approved marketing of the Preven Emergency Contraceptive Kit (Gynetics, Inc.) for this indication. The kit, which will require a prescription, includes four tablets, each containing 50 g of ethinyl estradiol and 0.25 mg of levonorgestrel, and a pregnancy test to rule out a pre-existing pregnancy, which would be a contraindication to taking the hormones.

Creatine, a natural amino acid derivative, and androstenedione, a testosterone precursor, are marketed as 'dietary supplements' in health food stores and are widely believed to enhance athletic performance. Both have been in the news recently because Mark McGwire, the baseball home-run record-setter, reportedly has said he takes both. Neither has been approved for any indication by the US Food and Drug Administration (FDA).

Tinzaparin sodium, a low molecular weight heparin, has been approved by the FDA for treatment of acute deep vein thrombosis.

Zoledronic acid (Zometa), a new bisphosphonate, has been approved by the FDA for intravenous (IV) treatment of hypercalcemia of malignancy.

Three beta interferons are widely used in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

A high-intensity, narrow-band blue light (ClearLight -Lumenis) approved by the FDA for treatment of moderate inflammatory acne vulgaris has been featured in some stories in fashion magazines. This review describes the etiology and treatment of acne, as well as the mechanism of action, clinical studies, adverse effects, dosage and cost of the drug.